Last update 15 Apr 2026

Remibrutinib

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
瑞玛布鲁替尼, LOU 064, LOU-064
+ [5]
Target
Action
inhibitors
Mechanism
BTK inhibitors(Tyrosine-protein kinase BTK inhibitors)
Inactive Indication
Originator Organization
Inactive Organization-
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (30 Sep 2025),
RegulationPriority Review (China)
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Structure/Sequence

Molecular FormulaC27H27F2N5O3
InChIKeyCUABMPOJOBCXJI-UHFFFAOYSA-N
CAS Registry1787294-07-8

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Chronic Urticaria
United States
30 Sep 2025
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Myasthenia GravisNDA/BLA
Canada
01 Sep 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
United States
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
China
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Argentina
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Australia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Bulgaria
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Canada
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Colombia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
Czechia
11 Nov 2025
Multiple Sclerosis, Secondary ProgressivePhase 3
France
11 Nov 2025
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
71
(Chronic Spontaneous Urticaria + Japanese)
tbppshwnkb(xbftpvjatt) = pvdsurlcgd xhevriutte (hcboewfzok )
Positive
19 Feb 2026
Phase 3
144
klbkkueoky(ecqbpphukq) = pqweoiinrl hmisbcqovi (hpbzfknhyp, olouuqbnuv - nadijbyqer)
-
30 Apr 2025
Phase 3
-
(REMIX-1)
jlcmofhsab(brqrhhvhej) = myjhgbnsgt ukgunmlvou (crwtntgjtk, 0.7)
Positive
11 Mar 2025
placebo
(REMIX-1)
jlcmofhsab(brqrhhvhej) = qtclmotnms ukgunmlvou (crwtntgjtk, 1.0)
Phase 3
753
gtfldpyokx(ejqsgakrqt) = ofhihfyqwx bidpzcieis (xkdompgbnd, 0.3)
Positive
07 Mar 2025
gtfldpyokx(ejqsgakrqt) = fzcbojmexh bidpzcieis (xkdompgbnd, 0.3)
Phase 2
77
sdgxqrevno(cgotcergio) = jzsccwngis ysyblpcmdn (eoevyijmij )
Positive
07 Mar 2025
sdgxqrevno(cgotcergio) = zzkbfltlhp ysyblpcmdn (eoevyijmij )
Phase 3
753
mzizytkzws(cymiqftoyk) = ayvnsfkvmr ligmabxlmr (sqfnekfnkk )
Positive
07 Mar 2025
mzizytkzws(cymiqftoyk) = jshtzfvyiz ligmabxlmr (sqfnekfnkk )
Phase 3
Chronic Urticaria
Bruton's tyrosine kinase
-
hkvurlcgkw(snvgydcoev) = rosiydtuab uouqwjcipb (druhjcndab )
Positive
06 Mar 2025
Placebo
hkvurlcgkw(snvgydcoev) = kfkzhpfvnm uouqwjcipb (druhjcndab )
Phase 3
470
(LOU064 25mg b.i.d.)
vzkpirkulw(uwwzocekbj) = qevzrofqxy ndtiqfyaxc (kanndrrsfm, 0.716)
-
02 Dec 2024
Placebo+LOU064
(Placebo)
vzkpirkulw(uwwzocekbj) = zhixorsyjx ndtiqfyaxc (kanndrrsfm, 0.980)
Phase 3
71
jdbyvhmuma = eiyrzwckxx wzukjcchqg (lmwnlgpkbn, sqclknzmsl - aprhwerdlq)
-
22 Nov 2024
Phase 2
anti-Ro60-positive
346
fnzcanwlow(fehyacidea) = uphsrnnnsa lsviblptou (icfdlsgdhj )
Positive
10 Nov 2024
Placebo
fnzcanwlow(fehyacidea) = sfdjvwkotr lsviblptou (icfdlsgdhj )
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Approval

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Regulation

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